K904390 is an FDA 510(k) clearance for the ANTI-HUMAN LEU-2A (CD8) PE. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 17, 1990, 83 days after receiving the submission on September 25, 1990.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K904390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1990 |
| Decision Date | December 17, 1990 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |